Encision, Inc. - FDA 510(k) Cleared Devices

Encision, Inc. designs and manufactures laparoscopic surgical instruments featuring Active Electrode Monitoring (AEM®) technology. The company, with a manufacturing facility in Boulder, US, specializes in burn protection systems and shielded surgical instruments for minimally invasive procedures.

Encision has received 10 FDA 510(k) clearances from 10 total submissions since 2007. All cleared devices fall within the General & Plastic Surgery category. The company's last FDA 510(k) clearance was in 2020, and the company is currently inactive with no recent submissions.

The company's product portfolio includes disposable and reusable electrodes, suction irrigation handsets, monitoring systems, and scissors designed to prevent capacitive coupling and insulation failure burns during laparoscopic surgery. The AEM enTouch 2X Scissor and ENDOSHIELD BURN PROTECTION SYSTEM represent key cleared devices addressing patient safety in electrosurgical applications.

Explore the complete list of cleared device names, product models, and clearance dates in the database.